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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,708 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,708 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2017 D & C Kit, part number CMP1466(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Custom Venous Kit, part number TVS4024(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Major Laparotomy Pack - NS, part number AMS4347 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic P... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 C-Tray Pack, part number PSS2707(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 General Pack, part number AMS2967(A General Pack, part number AMS3239(A Gen... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Arthroscopy Pack, part number AMS6559 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Newport Coast Basic Pack, part number 007484-1 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Basic Setup Tray, part number AMS6414 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 HSG Pack, part number PSS3287 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Laparoscopy Pack (1184), part number AMS6562 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Total Hip Pack, part number PSS2956 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Major Kit, part number PHC1307(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Transvaginal Pack, part number CMP1767 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Knee Pack, part number AMS4211 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Orbitofacial Pack, part number AMS5850(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Ortho Pack, part number PSS3466(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Major Pack (1345), part number AMS6565 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Surgical Pack, part number PSS3540(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Minor/General/Ortho Pack, part number PSS3258(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 General Surgery Pack, part number PSS1380(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Upper Torso Tray, part number PSS1554(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Nasal Pack, part number PSS2186 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm D... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm D... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm D... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 23, 2016 BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ... Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n... Class II Becton Dickinson & Company
Dec 12, 2016 AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG... Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Pr... Class II Medtronic Navigation, Inc.
Dec 9, 2016 Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... During internal testing conducted as part of next generation product development, it was discover... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Nov 16, 2016 Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio... Class II Medtronic Inc
Nov 10, 2016 ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire... Class II Medtronic Inc
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.